Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)— 510(k) K222047
Substantially EquivalentElekta Solutions AB
FDA 510(k) clearance K222047 for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant), Substantially Equivalent on 2022-10-26. Applicant: Elekta Solutions AB. Device class: 2.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Code IWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.5750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code IWB
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